Endoscopic device and system

ABSTRACT

An endoscopic system may include a catheter or tubing and at least one optical sensor disposed along the catheter or tubing and configured to capture image information from a body lumen when disposed within the body lumen and activated. The system may further include an untethered module operatively arranged with the at least one optical sensor and configured to store or transmit image information captured by the at least one optical sensor. The catheter or tubing, at least one optical sensor and module may be portable during use.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 14/293,994, filed Jun. 2, 2014, which is a continuation of application Ser. No. 13/071,937, filed Mar. 25, 2011, which claims the benefit of U.S. Provisional Application No. 61/321,911, filed Apr. 8, 2010, each of which is hereby incorporated by reference in its entirety.

BACKGROUND

Sleep disordered breathing, including snoring and obstructive sleep apnea, affects tens of millions of adults in the United States. It is associated with substantial cardiovascular morbidity and mortality, endocrine disturbances, excessive daytime sleepiness, quality of life and performance deficits, and motor vehicle crashes.

Treatment options include behavioral measures such as weight loss, positive airway pressure therapy, surgery, and oral appliances. All treatments have strengths and weaknesses, and in particular surgical treatment has outcomes that vary widely among patients and procedures.

The evaluation of patients with sleep disordered breathing may improve outcomes of surgical treatment. The goals of such evaluation include characterizing (1) the pattern of airway obstruction (involving primarily the palate/tonsils region, tongue base, epiglottis, and/or lateral pharyngeal walls) and (2) the site of sound production. Existing upper airway examination techniques, however, may not provide an accurate evaluation of the pharynx during natural sleep as explained below.

A flexible endoscope such as the Olympus fiberscope or the Olympus video scope may be utilized to examine a patient's upper airway during wakefulness, natural sleep or sedation. Examination during natural sleep may provide the best results, but attempts to perform traditional natural sleep endoscopy have been largely abandoned for multiple reasons, including the fact that it requires that an operator be present to hold the endoscope in place during the often prolonged period needed for patients to fall asleep with the endoscope in place. The behavior of the upper airway during wakefulness differs dramatically compared to natural sleep, which makes examinations during wakefulness insufficient. Sedation is costly because it requires a controlled environment and the involvement of highly trained personnel and specialized equipment. In addition, sedation may alter the pattern of upper airway obstruction.

Current examinations during wakefulness, sedation, and natural sleep are also limited because their duration is typically no more than 10-15 minutes due to personnel and financial constraints. It is unclear whether this abbreviated examination adequately describes pharyngeal behavior through an entire night of sleep.

There is enthusiasm among clinicians and patients alike for improved surgical evaluation techniques, particularly techniques that provide an accurate, dynamic assessment of the upper airway during natural sleep without the need for sedation, the presence of a clinician, or the associated costs.

SUMMARY

An endoscopic device may include a catheter or tubing and at least two optical sensors spaced apart from each other along the catheter or tubing such that, for example, image information from different regions of a body lumen partially or completely separated by an obstruction is captured when each of the at least two optical sensors is disposed within one of the regions and activated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of an endoscopic system.

FIG. 2 is a schematic diagram of another endoscopic system.

FIG. 3 is a schematic diagram of a data and/or power module of an endoscopic system.

FIG. 4 is a schematic diagram of the sensor arrangement of the endoscopic system of FIG. 1.

FIG. 5 is a schematic diagram of another sensor arrangement for an endoscopic system.

FIG. 6 is a schematic diagram of yet another sensor arrangement for an endoscopic system.

FIG. 7A is a perspective view of one of the optical sensors of the endoscopic system of FIG. 1.

FIG. 7B is a side view, in cross-section, of the optical sensor of FIG. 7A.

FIG. 8A is a perspective view of another optical sensor of an endoscopic system.

FIG. 8B is a side view, in cross-section, of the optical sensor of FIG. 8A.

FIGS. 9A and 9B are front and rear schematic views, respectively, of the endoscopic system of FIG. 2 fitted to a patient's head in the in-use position.

FIGS. 10A and 10B are side views, in sagittal cross-section, of the patient's head and optical sensor arrangement of FIGS. 9A and 9B.

FIGS. 11A and 11B are front and rear schematic views, respectively, of another embodiment of an endoscopic system fitted to a patient's head in the in-use position.

FIGS. 12A and 12B are front and rear schematic views, respectively, of yet another endoscopic system fitted to a patient's head in the in-use position.

DETAILED DESCRIPTION

As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms. The figures are not necessarily to scale; some features may be exaggerated or minimized to show details of particular components. Moreover, similarly numbered elements (e.g., elements 20 and 120, elements 21, 321, and 621, elements 26 and 326, elements 170 and 670) may have similar descriptions. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.

Referring to FIG. 1, an embodiment of an endoscopic system 10 may be used to collect visual and/or audio information from a patient's airway. This information may be displayed and/or played by the output system 12. The endoscopic system 10 may include an optical sensor arrangement 14, a data and/or power module 16, a sensor cord 18 connecting the sensor arrangement 14 and module 16, and a skullcap 19. Other arrangements are also possible and will be discussed in further detail below.

The module 16 may be removably attached with the skullcap 19 via VELCRO, a snap feature or other suitable attachment mechanism. The skullcap 19 may include an elastic band 20 configured to secure the skullcap 19 and sensor cord 18 to a patient's head.

The sensor arrangement 14, in the embodiment of FIG. 1, includes a body portion 21 and a pair of legs 22 of differing lengths projecting there from. Each of the legs 22 has an optical sensor 24 disposed at an end thereof. The sensor arrangement 14 also includes a connector 26 (e.g., a USB port, a fiber optic connector, etc.) disposed at an end of the body portion 21 opposite the legs 22 and capable of, for example, connecting the optical sensors 24 with a mating connector 28 of the sensor cord 18 and/or a mating connector 30 of the display system 12.

When the sensor arrangement 14 is connected with the module 16, the module 16 may store information received from the sensor arrangement 14 for later access. For example, the module 16 may store collected information while a patient is asleep. An investigator may then access the stored information at a later time. When the sensor arrangement 14 is connected with the display system 12, information captured by the sensor arrangement 14 may be viewed in real-time.

The display system 12 may include a display screen 32 and any suitable/known decoder device 34 (e.g., a non-wearable version of module 16, a video monitor, a smart phone, a personal computer with suitable hardware/software, etc.) The decoder device 34 may be configured to interpret information from the sensor arrangement 14 and generate appropriate signals for (i) display and/or play by the display screen 32 and/or (ii) data storage in a storage device (not shown).

Referring to FIG. 2, the sensor arrangement 114 is directly connected with the module 116. The module 116 may wirelessly transmit (and/or store) information from the sensor arrangement 114 to the decoder device 134 for real-time display and/or play. Other arrangements are, of course, also possible. For example, the module 116 may wirelessly transmit information from the sensor arrangement 114 to a remote storage device (not shown). Alternatively, the module 116 may store the information from the sensor arrangement 114 for later access, etc.

Referring to FIG. 3, an embodiment of a data and/or power module 216 may include a bundle coupling 236, a microphone input 238, a microprocessor 240, a memory 242 (e.g., a card reader, etc.), and a radiofrequency transmitter 244 all mounted on a printed circuit board 246. The module 216 may also include a rechargeable power source 250 (e.g., rechargeable batteries) disposed, in this embodiment, on a side of the circuit board 246 opposite the microprocessor 240, and various switches 252 (e.g., a power switch, a microphone switch, etc.) The coupling 236 may include a recharging port 248, image sensors 254, and associated LEDs 256. Hence, the module 216 is self-contained and may operate untethered. That is, it may operate without being attached via cording to a separate power source, processor, memory, etc. (unlike certain conventional arrangements).

In other embodiments, the image sensors 254, for example, may be replaced with suitable connectors for cameras; the transmitter 244 may be replaced with a suitable wired data output, etc.

Information received via the coupling 236 and/or the microphone input 238 may be processed by the microprocessor 240 in any suitable/known fashion and stored in the memory 242 and/or wirelessly transmitted via the radiofrequency transmitter 244.

Referring to FIG. 4, the sensor arrangement 14 of FIG. 1 is shown in further detail. The legs 22 are of different lengths such that the optical sensor 24 disposed at the end of the longer leg 22 may capture images from an area of a patient's airway different than the images captured by the optical sensor 24 disposed at the end of the shorter leg 22. Given this arrangement, different regions within the airway may be observed at the same time, even if there is an intervening structure that obstructs the simultaneous visualization of both (or all) areas with a single optical sensor. For snoring and sleep apnea, as an example, the soft palate can isolate two areas of the airway (above and below) if it completely or partially obstructs the airway. The use of two cameras or other methods of image acquisition from two sites (as opposed to one) enables the simultaneous visualization of the two areas.

In the embodiment of FIG. 4, the optical sensors 24 are spaced apart at a distance that may be greater than or equal to 5 mm. That is, the length of the longer leg 22 may be at least 5 mm greater than that of the shorter leg 22. In other embodiments, the optical sensors 24 may be spaced at any distance suitable for capturing images of different regions of a patient's airway (e.g., 5 mm, 10 mm, 50 mm, etc.)

Some embodiments may have more or less than two legs 22 and two associated optical sensors 24. For example, a sensor arrangement may have three legs each with an optical sensor disposed at an end thereof. The number of legs (and thus the number of optical sensors) may, however, be limited by the effective diameter of a patient's airway.

Referring to FIG. 5, the legs 322 of the sensor arrangement 314 have the same or different lengths, but a clamp 358 (band, locking mechanism, etc.) may be used to effectively change the length of one of the legs 322 relative to the other. This arrangement may be used to tailor the distance between the optical sensors 324 for a particular patient while using a standard sensor arrangement.

Referring to FIG. 6, the optical sensors 424 are disposed (and spaced apart) along the body portion 421 of the sensor arrangement 414. This arrangement, relative to the embodiments of FIGS. 4 and 5, may allow the packaging of several of the optical sensors 424 without substantially altering the diameter of the sensor arrangement 414.

Referring to FIGS. 7A and 7B, one of the optical sensors 24 of FIG. 1 is shown in further detail. In this embodiment, the optical sensor 24 includes a camera 60 and associated lens 62. The camera 60 may receive power from and transmit image information to the module 16 of FIG. 1 via electrical/communication lines 64. Illumination fibers 66 in optical communication with, for example, LEDs within the module 16 of FIG. 1 are disposed within the leg 22. The illumination fibers 66 provide light for the camera 60.

The optical sensor 24 may have a diameter ranging from approximately 6 mm to 10 mm. The leg 22 may have a diameter ranging from approximately 2 mm to 5 mm. Other diameters and sizes, however, are also possible depending on, for example, camera size, fiber diameter, etc.

Referring to FIGS. 8A and 8B, another embodiment of an optical sensor 524 is shown in further detail. The optical sensor 524 includes a video fiber optic element 568 and associated lens 562. Because the optical sensor 524 does not include an internal camera (similar to the optical sensor 24 of FIGS. 7A and 7B), its diameter may range in size from approximately 3 mm to 8 mm. Other diameters and sizes, however, are also possible depending on, for example, fiber diameter, etc. In other embodiments, any suitable/known optical sensor may be used.

Referring to FIGS. 9A, 9B, 10A and 10B, the endoscopic system 110 of FIG. 2 is fitted to a patient's head. The sensor arrangement 114 is positioned such that the optical sensors 124 capture image information from different regions within the patient's airway. More specifically, the legs 122 are arranged and the optical sensors 124 are positioned, in this example, such that the optical sensors 124 capture image information from the retropalatal and retrolingual regions of the patient's pharynx regardless of whether there is an obstruction between the two regions (e.g., the soft palate obstructing the airway, as in FIG. 10B). The sensor arrangement 114 may also be arranged, of course, to capture, for example, image information from a single region or multiple overlapping or non-overlapping regions of any body lumen.

The skullcap 119 is placed over the patient's head and the module 116 is attached thereto with, for example, a snap feature (not shown). The body portion 121 is attached to the patient's cheek and nose with adhesive 170. This arrangement may permit the patient to wear (attended or unattended) the endoscopic system 110 for extended periods of time while image information from their airway is collected and, for example, stored within the module 116.

Referring to FIGS. 11A and 11B, another embodiment of an endoscopic system 610 is fitted to a patient's head. In this embodiment, the headband 620 is larger than in the embodiments of, for example, FIGS. 1 and 2. Hence, the module 616 may be attached directly to the front of the headband 620 (or the rear/side as desired).

Referring to FIGS. 12A and 12B, yet another embodiment of an endoscopic system 710 is fitted to a patient's head. The headband 720, in this embodiment, encompasses the nose of the patient and provides a harness in the rear where the module 716 may be attached. In this embodiment, the body portion 721 need not be attached directly to the patient's face. Rather, the body portion 721 is attached to the headband 720 via snaps 772 or other suitable attachment features. Other arrangements are also possible.

While embodiments of the invention have been illustrated and described, it is not intended that these embodiments illustrate and describe all possible forms of the invention. Rather, the words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. As an example, certain embodiments may be used to collect images over a period of time from any body lumen (e.g., nasal cavity, esophagus, stomach, small intestine and large intestine, etc.) As another example, while endoscopic systems including either an internal (to the body) camera with an external light source and battery or an external camera, light source and battery have been explicitly disclosed, other embodiments of endoscopic systems may include an internal camera, battery and light source, an internal camera and light source with an external battery, an internal camera and battery with an external light source, or any other internal/external combination of components. As yet another example, certain embodiments may be fitted to any part of a patient's body via suitable cuffs/adhesives/bands/pockets/etc. 

What is claimed is:
 1. A method for examining an airway of a human patient comprising: inserting into a nasal cavity of the patient an endoscopic device including a catheter or tubing and at least two optical sensors attached to the catheter or tubing; and removably but fixably securing the catheter or tubing to position at least one of the at least two optical sensors in a retropalatal region of an upper airway of the patient and at least one other of the at least two optical sensors in a retrolingual region of the upper airway but not in an esophagus of the patient such that the at least two optical sensors are spaced away from each other along the catheter or tubing and that image information from the retropalatal region is captured by the one of the at least two optical sensors and image information from the retrolingual region is captured by the at least one other of the at least two optical sensors when the at least two optical sensors are activated.
 2. The method of claim 1 further comprising: operatively arranging the endoscopic device with an untethered module, that includes at least one of a power source, memory, transmitter, microphone and illumination source, configured to store or transmit wirelessly image information captured by the at least two optical sensors, wherein the catheter or tubing, at least two optical sensors and module are portable during use.
 3. The method of claim 1 further comprising: operatively arranging the endoscopic device with an untethered module including at least one of a power source, memory, transmitter, microphone and illumination source.
 4. The method of claim 1 further comprising: operatively arranging the endoscopic device with an untethered module and a band or cuff attachable with the module and configured to secure the module to a body of the patient.
 5. The method of claim 1 further comprising: removably but fixably securing the catheter or tubing to position the at least two optical sensors such that image information from the retropalatal region is captured by at least one of the al least two optical sensors and image information from the retrolingual region is captured by at least one other of the at least two optical sensors when the at least two optical sensors are activated regardless of whether a soft palate of a patient completely obstructs the airway between the retropalatal region and the retrolingual region.
 6. The method of claim 1 further comprising: the catheter or tubing having at least two branches of unequal length extending from a common joint, each of the branches having an optical sensor attached thereto.
 7. A method for examining an airway of a human patient comprising: inserting into a nasal cavity of the patient an endoscopic device including a catheter or tubing and at least one optical sensor attached to the catheter or tubing; and removably but fixably securing the catheter or tubing in a retropalatal region of an upper airway of the patient but not in an esophagus of the patient such that image information from the retropalatal region is captured when the at least one optical sensor is activated.
 8. The method of claim 7 further comprising: operatively arranging the endoscopic device with an untethered module, that includes at least one of a power source, memory, transmitter, microphone and illumination source, configured to store or transmit wirelessly image information captured by the at least one optical sensor, wherein the catheter or tubing, at least one optical sensor and module are portable during use.
 9. The method of claim 7 further comprising: operatively arranging the endoscopic device with an untethered module including at least one of a power source, memory, transmitter, microphone and illumination source.
 10. The method of claim 7 further comprising: operatively arranging the endoscopic device with an untethered module and a band or cuff attachable with the module and configured to secure the module to a body of the patient.
 11. A method for examining a human patient comprising: inserting into a hollow body cavity of the patient an endoscopic device including a catheter or tubing having at least two branches of unequal length extending from a common joint, each of the branches having an optical sensor attached thereto; and positioning the branches within the cavity such that the at least two optical sensors are spaced away from each other and that image information from different regions of the cavity is captured when the at least two optical sensors are activated during natural sleep; and removably but fixably securing a portion of the catheter or tubing to a body of the patient.
 12. The method of claim 11 further comprising: operatively arranging the endoscopic device with an untethered module, that includes at least one of a power source, memory, transmitter, microphone and illumination source, configured to store or transmit wirelessly image information captured by the at least two optical sensors, wherein the catheter or tubing, at least two optical sensors and module are portable during use.
 13. The method of claim 11 further comprising: operatively arranging the endoscopic device with an untethered module including at least one of a power source, memory, transmitter, microphone and illumination source.
 14. The method of claim 11 further comprising: operatively arranging the endoscopic device with an untethered module and a band or cuff attachable with the module and configured to secure the module to the body.
 15. A method for examining a human patient comprising: inserting into a hollow body cavity of the patient an endoscopic device including a catheter or tubing and at least one optical sensor attached to the catheter or tubing; positioning the catheter or tubing such that image information from the at least one optical sensor is captured during natural sleep when the at least one optical sensor is activated; and removably but fixably securing a portion of the catheter or tubing to a body of the patient.
 16. The method of claim 15 further comprising: operatively arranging the endoscopic device with an untethered module, that includes at least one of a power source, memory, transmitter, microphone and illumination source, configured to store or transmit wirelessly image information captured by the at least one optical sensor, Wherein the catheter or tubing, at least one optical sensor and module are portable during use.
 17. The method of claim 15 further comprising: operatively arranging the endoscopic device with an untethered module including at least one of a power source, memory, transmitter, microphone and illumination source.
 18. The method of claim 15 further comprising: operatively arranging the endoscopic device with an untethered module and a band or cuff attachable with the module and configured to secure the module to the body.
 19. The method of claim 15 further comprising at least two optical sensors attached to the catheter or tubing. 